Astellas and Apellis are competing for market share in the U.S. for their geographic atrophy (GA) treatments, Izervay and Syfovre. However, they are facing challenges in getting these treatments approved in Europe. The European Committee for Medicinal Products for Human Use (CHMP) has rejected Apellis’ Syfovre application twice, and Astellas has withdrawn its application for Izervay after discussions with European regulators.
Astellas remains optimistic about Izervay’s benefits and plans to continue working with global regulators to make the treatment available. This setback is significant for Astellas, which invested $5.9 billion to acquire the company that developed Izervay. Despite being disappointed by the CHMP’s decision, Astellas highlights the positive impact of the drug in the U.S. and its commitment to global patient needs.
The CHMP rejected Syfovre because, although it slowed GA lesion growth, it didn’t provide significant clinical benefits. Apellis plans to seek a reexamination of this decision. After its U.S. approval in February 2023, Syfovre’s launch was initially hampered by reports of eye inflammation but has since recovered, with significant sales reported.
Izervay, approved by the FDA in August 2022, also showed promising sales. It carries warnings for potential side effects like inflammation and infections and is administered monthly. Its approval was based on trials showing it could slow disease progression by up to 35% over a year.
Astellas and Apellis may dominate the GA market for a few years, as competitors Roche and AstraZeneca are still in earlier development stages. GA affects about 1.5 million people in the U.S., but many are undiagnosed. Without treatment, a significant portion of GA patients risk severe vision loss.